Reduction Mammaplasty for BreastRelated Symptoms Policy Number: 7.01.21 Origination: 7/2005 Last Review: 7/2016 Next Review: 7/2017 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for reduction mammaplasty when the criteria shown below are met. When Policy Topic is covered Reduction mammaplasty may be considered medically necessary for the treatment of macromastia when well-documented clinical symptoms are present. One bullet from criteria #1 and one bullet from criteria #2 must be present to indicate medical necessity: Documentation of a minimum 6-week history of shoulder, neck, or back pain related to macromastia that is not responsive to conservative therapy, such as an appropriate support bra, exercises, heat/cold treatment, and appropriate nonsteroidal anti-inflammatory agents/muscle relaxants. Recurrent or chronic intertrigo between the pendulous breast and the chest wall. Criteria #1 Removal of at least 500 grams per breast; OR The average grams of tissue removed per breast falls above the 22 nd percentile, relative to the patient’s body surface area Body Surface Calculator (Haycock Formula): http://medicalpolicy.bluekc.com?Calculator=BS AND one of the following: Criteria #2 Documentation of a minimum 6-week history of shoulder, neck, or back pain related to macromastia that is not responsive to conservative therapy, such as an appropriate support bra, exercises, heat/cold treatment, and appropriate non-steroidal anti-inflammatory agents/muscle relaxants; OR Intertrigo between the pendulous breast and the chest wall When Policy Topic is not covered It should be noted that the emotional and psychosocial distress associated with body appearance does not constitute a medical rationale for reduction mammaplasty, and thus these indications would be considered cosmetic in nature. Reduction mammoplasty is considered cosmetic for all other indications not meeting the above criteria. Considerations Body surface area and cutoff weight of average breast tissue removed BSA (m²) = 0.024265 x Height(cm)0.3964 x Weight(kg)0.5378 Schnur Sliding Scale Body Surface Area (m2) Average grams of tissue per breast to be removed 1.35 199 1.40 218 1.45 238 1.50 260 1.55 284 1.60 310 1.65 338 1.70 370 1.75 404 1.80 441 1.85 482 1.90 527 1.95 575 2.00 628 2.05 687 2.10 750 2.15 819 2.20 895 2.25 978 2.30 1068 2.35 1167 2.40 1275 2.45 1393 2.50 1522 2.55 1662 2.60 1806 2.65 1972 2.70 2154 2.75 2352 2.80 2568 2.85 2804 2.90 3061 2.95 3343 3.00 3650 3.05 3985 3.10 4351 3.15 4750 3.20 5186 3.25 5663 3.30 6182 3.35 6750 3.40 7369 3.45 8045 3.50 8783 3.55 9589 3.60 10468 3.65 11428 3.70 12476 3.75 13619 3.80 14867 3.85 16230 3.90 17717 3.95 19340 4.00 21112 4.05 23045 4.10 25156 4.15 27459 4.20 29972 4.25 32716 4.30 35710 4.35 38977 4.40 42543 4.45 46435 4.50 50682 4.55 55316 4.60 60374 4.65 65893 4.70 71915 4.75 78487 4.80 85658 Description of Procedure or Service Populations Individuals: With symptomatic macromastia Interventions Interventions of interest are: Reduction mammaplasty Comparators Comparators of interest are: Nonsurgical treatment Outcomes Relevant outcomes include: Symptoms Functional outcomes Summary Macromastia, or gigantomastia, is a condition that describes breast hyperplasia or hypertrophy. Macromastia may result in clinical symptoms such as shoulder, neck, or back pain, or recurrent intertrigo in the mammary folds. In addition, macromastia may be associated with psychosocial or emotional disturbances related to the large breast size. Reduction mammaplasty is a surgical procedure designed to remove a variable proportion of breast tissue to address emotional and psychosocial issues and/or relieve the associated clinical symptoms. The evidence for reduction mammaplasty in individuals who have symptomatic macromastia includes randomized controlled trials and case series. Relevant outcomes are symptoms and functional outcomes. These studies indicate that reduction mammaplasty is effective at decreasing breast-related symptoms such as pain and discomfort. There is also evidence that functional limitations related to breast hypertrophy are improved following reduction mammaplasty. These outcomes are achieved with acceptable complication rates. Overall, reduction mammaplasty in appropriately selected patients is associated with improvements in several important health outcomes. Background Macromastia, or gigantomastia, is a condition that describes breast hyperplasia or hypertrophy. Macromastia may result in clinical symptoms such as shoulder, neck, or back pain, or recurrent intertrigo in the mammary folds. In addition, macromastia may be associated with psychosocial or emotional disturbances related to the large breast size. Reduction mammaplasty is a surgical procedure designed to remove a variable proportion of breast tissue to address emotional and psychosocial issues and/or relieve the associated clinical symptoms. While the literature search identified many articles that discuss the surgical technique of reduction mammaplasty and document that reduction mammaplasty is associated with a relief of physical and psychosocial symptoms, 1-9 an important issue is whether reduction mammaplasty is medically necessary or cosmetic in nature. For some patients, the presence of medical indications is clear-cut, ie, a clear documentation of recurrent intertrigo or ulceration secondary to shoulder grooving. For some patients, the documentation differentiating between a cosmetic and medically necessary procedure will be unclear. Criteria for medically necessary reduction mammaplasty are not well-addressed in the published medical literature. Some policies regarding medical necessity of reduction mammaplasty are based on the weight of removed breast tissue. The basis of weight criteria is not related to the outcomes of surgery, but to surgeons retrospectively classifying cases as cosmetic or medically necessary. In 1991, Schnur et al, at the request of thirdparty payers, developed a sliding scale.10 This scale was based on survey responses of 92 of 200 solicited plastic surgeons, who reported the height, weight, and amount of breast tissue removed from each breast from the last 15 to 20 reduction mammaplasties they had performed. Surgeons were also asked if the procedures were performed for cosmetic or medically necessary reasons. The data were then used to create a chart relating the body surface area and the cutoff weight of breast tissue removed that differentiated cosmetic and medically necessary procedures. Based on their estimates, those with breast tissue removed weight above the 22nd percentile line likely had the procedure performed for medical reasons, while those below the 5th percentile line likely had the procedure performed for cosmetic reasons; those falling between the cutpoints had the procedure formed for mixed reasons. See Appendix Table 1 for the Schnur Sliding Scale. In 1999, Schnur reviewed the experience of the sliding scale as a coverage criterion and reported that, while many payers had adopted it, many had also misused it.11 Schnur pointed out that if a payer used weight of resected tissue as a coverage criterion, then if the weight fell below the 5th percentile line, the reduction mammaplasty would be considered cosmetic; if above the 22nd percentile line, it would be considered medically necessary; and if between these cutpoints, it would be considered on a case-by-case basis. Schnur also questioned the frequent requirement that a woman be within 20% of her ideal body weight. While weight loss might relieve symptoms, durable weight loss is notoriously difficult and may be unrealistic in many cases. Rationale This evidence review was originally created in 1995 and has been updated with searches of the MEDLINE database. The most recent literature review was performed for the period of October 2014 through January 20, 2016. The following is a summary of the key findings to date. Efficacy in Reducing Symptoms Observational Studies Singh and Losken (2012) reported on a systematic review of studies reporting outcomes after reduction mammaplasty.12 The reviewers found reduction mammaplasty improved functional outcomes including pain, breathing, sleep, and headaches. Additional psychological outcomes noted included improvements in self-esteem, sexual function, and quality of life (QOL). In 2002, Kerrigan et al published the results of the BRAVO (Breast Reduction: Assessment of Value and Outcomes) study, a registry of 179 women undergoing reduction mammaplasty.13 Women were asked to complete QOL questionnaires and a physical symptom count both before and after surgery. The physical symptom count focused on the number of symptoms present that were specific to breast hypertrophy and included upper back pain, rashes, bra strap grooves, neck pain, shoulder pain, numbness, and arm pain. In addition, the weight and volume of resected tissue were recorded. Results were compared with a control group of patients with breast hypertrophy, defined as size DD bra cup, and normal-sized breasts, who were recruited from the general population. The authors proposed that the presence of 2 physical symptoms might be an appropriate cutoff for determining medical necessity for breast reduction. For example, while 71.6% of the hypertrophic controls reported none or 1 symptom, only 12.4% of those considered surgical candidates reported none or 1 symptom. This observation is difficult to evaluate because the study did not report how surgical candidacy was determined. The authors also reported that none of the traditional criteria for determining medical necessity for breast reduction surgery (height, weight, body mass index [BMI], bra cup size, or weight of resected breast tissue) had a statistically significant relationship with outcome improvement. The authors concluded that the determination of medical necessity should be based on patients’ self-reported symptoms rather than more objectively measured criteria, such as weight of excised breast tissue. Randomized Controlled Trials In 2008, Sabino Neto et al assessed functional capacity in which 100 patients, ages 18 to 55 years, were randomized to reduction mammaplasty or waiting list control.7 Forty-six patients from each group completed the study. At the onset of the study and 6 months later, patients were assessed for functional capacity using the Roland-Morris Disability Questionnaire (0=best performance, 24=worst performance) and for pain using a visual analog scale (VAS). The reduction mammaplasty group showed improvement in functional status, with an average score of 5.9 preoperatively to 1.2 within 6 months postoperatively (p<0.001 for pre-post comparison within the mammaplasty group) versus an unchanged average score of 6.2 in the control group on the first and second evaluations. Additionally, pain in the lower back region decreased on the VAS from an average of 5.7 preoperatively to 1.3 postoperatively (p<0.001 for pre-post comparison within the mammaplasty group) versus VAS average scores in the control group of 6.0 and 5.3 on the first and second evaluations, respectively (no significant change). Also in 2008, Saariniemi et al reported on QOL and pain in 82 patients who were randomized to reduction mammaplasty or a nonoperative group and evaluated at baseline and 6 months later.9 The authors reported that the mammaplasty group had significant improvements in QOL, as measured by the Physical Component Summary score of the 36-Item Short-Form Health Survey (SF-36; change, +9.7 vs +0.7, p<0.001), the Utility Index score (SF-6D; change, +17.5 vs +0.6), the index score of QOL (SF-15D; change, +8.6 vs +0.06, p<0.001), and SF-36 Mental Component Summary score (change, +7.8 vs -1.0, p<0.002). There were also improvements in breast-related symptoms, as measured by the Finnish BreastAssociated Symptoms questionnaire score (-47.9 vs -3.5, p<0.001), and the Finnish Pain Questionnaire score (-21.5 vs -1.0, p<0.001). Iwuagwu et al reported on 73 patients randomized to receive reduction mammaplasty within 6 weeks or after a 6-month waiting period to assess lung function.8 All patients had symptoms related to macromastia. Postoperative lung function correlated with the weight of breast tissue removed, but there were no significant improvements in any lung function parameters for the mammaplasty group compared with the control group. Beraldo et al reported trial of 60 patients randomized to receive reduction mammaplasty or no surgery.14 The study outcomes were sexual function and depressive symptoms. At 6 months, Female Sexual Function Index scores were higher in the reduction mammaplasty group (27.5 vs 22.5, p<0.001). Level of depression, as measured by the Beck Depression Inventory, was lower in the reduction mammaplasty group (7.2 vs 13.7, p=0.01). Analyses using categories of sexual function or depression showed similar results. Studies Reporting Complications Thibaudeau et al (2010) conducted a systematic review to evaluate breastfeeding after reduction mammaplasty.15 After a review of literature from 1950 through December 2008, the authors concluded that reduction mammaplasty does not reduce the ability to breastfeed. In women who had reduction mammaplasty, breastfeeding rates were comparable in the first month postpartum to rates in the general population in North America. In 2011, Chen et al reported on a review of claims data to compare complication rates after breast surgery in 2403 obese and 5597 nonobese patients. 16 Of these patients, breast reduction was performed in 1939 (80.7%) in the study group and 3569 (63.8%) in the control group. Obese patients had significantly more claims for complications within 30 days after breast reduction surgery than nonobese patients (14.6% vs 1.7%, respectively, p<0.001). Complications included inflammation, infection, pain, and seroma/hematoma development. Also in 2011, Shermak et al reported on a review of claims data comparing complication rates by age after breast reduction surgery in 1192 patients. 17 Infection occurred more frequently in patients older than 50 years of age (odds ratio [OR], 2.7; p=0.003). Additionally, women older than 50 years experienced more wound healing problems (OR=1.6; p=0.09) and reoperative wound débridement (OR=5.1; p=0.07). Other retrospective evaluations of large population datasets have reported an increased incidence of perioperative and postoperative complications with high BMI.18,19 Section Summary: Efficacy in Reducing Symptoms Several randomized trials and observational studies have shown improvements in several measures of function and QOL. Ongoing and Unpublished Clinical Trials A search of ClinicalTrials.gov in January 2016 did not identify any ongoing or unpublished trials that would likely influence this review. Summary of Evidence The evidence for reduction mammaplasty in individuals who have symptomatic macromastia includes randomized controlled trials and case series. Relevant outcomes are symptoms and functional outcomes. These studies indicate that reduction mammaplasty is effective at decreasing breast-related symptoms such as pain and discomfort. There is also evidence that functional limitations related to breast hypertrophy are improved following reduction mammaplasty. These outcomes are achieved with acceptable complication rates. Overall, reduction mammaplasty in appropriately selected patients is associated with improvements in several important health outcomes. Practice Guidelines and Position Statements The American Society of Plastic Surgeons (ASPS) has issued practice guidelines and a companion document on criteria for third-party payers for reduction mammaplasty.20-22 ASPS indicates level I evidence has shown reduction mammaplasty is effective in treating symptomatic breast hypertrophy, which “is defined as a syndrome of persistent neck and shoulder pain, painful shoulder grooving from brassiere straps, chronic intertriginous rash of the inframammary fold, and frequent episodes of headache, backache, and neuropathies caused by heavy breasts caused by an increase in the volume and weight of breast tissue beyond normal proportions.” ASPS also indicates the volume or weight of breast tissue resection should not be criteria for reduction mammaplasty. If 2 or more symptoms are present all or most of the time, reduction mammaplasty is appropriate. U.S. Preventive Services Task Force Recommendations Not applicable. Medicare National Coverage There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers. References 1. Dabbah A, Lehman JA, Jr., Parker MG, et al. Reduction mammaplasty: an outcome analysis. Annals of plastic surgery. Oct 1995;35(4):337-341. PMID 8585673 2. Schnur PL, Schnur DP, Petty PM, et al. Reduction mammaplasty: an outcome study. Plastic and reconstructive surgery. Sep 1997;100(4):875-883. PMID 9290655 3. Hidalgo DA, Elliot LF, Palumbo S, et al. Current trends in breast reduction. Plastic and reconstructive surgery. Sep 1999;104(3):806-815; quiz 816; discussion 817-808. PMID 10456536 4. Glatt BS, Sarwer DB, O'Hara DE, et al. A retrospective study of changes in physical symptoms and body image after reduction mammaplasty. Plastic and reconstructive surgery. Jan 1999;103(1):76-82; discussion 83-75. PMID 9915166 5. Collins ED, Kerrigan CL, Kim M, et al. The effectiveness of surgical and nonsurgical interventions in relieving the symptoms of macromastia. Plastic and reconstructive surgery. Apr 15 2002;109(5):1556-1566. PMID 11932597 6. Iwuagwu OC, Walker LG, Stanley PW, et al. Randomized clinical trial examining psychosocial and quality of life benefits of bilateral breast reduction surgery. The British journal of surgery. Mar 2006;93(3):291-294. PMID 16363021 7. Sabino Neto M, Dematte MF, Freire M, et al. Self-esteem and functional capacity outcomes following reduction mammaplasty. Aesthetic surgery journal / the American Society for Aesthetic Plastic surgery. Jul-Aug 2008;28(4):417-420. PMID 19083555 8. Iwuagwu OC, Platt AJ, Stanley PW, et al. Does reduction mammaplasty improve lung function test in women with macromastia? Results of a randomized controlled trial. Plastic and reconstructive surgery. Jul 2006;118(1):1-6; discussion 7. PMID 16816661 9. Saariniemi KM, Keranen UH, Salminen-Peltola PK, et al. Reduction mammaplasty is effective treatment according to two quality of life instruments. A prospective randomised clinical trial. Journal of plastic, reconstructive & aesthetic surgery : JPRAS. Dec 2008;61(12):1472-1478. PMID 17983882 10. Schnur PL, Hoehn JG, Ilstrup DM, et al. Reduction mammaplasty: cosmetic or reconstructive procedure? Annals of plastic surgery. Sep 1991;27(3):232-237. PMID 1952749 11. Schnur PL. Reduction mammaplasty-the schnur sliding scale revisited. Annals of plastic surgery. Jan 1999;42(1):107-108. PMID 9972729 12. Singh KA, Losken A. Additional benefits of reduction mammaplasty: a systematic review of the literature. Plastic and reconstructive surgery. Mar 2012;129(3):562-570. PMID 22090252 13. Kerrigan CL, Collins ED, Kim HM, et al. Reduction mammaplasty: defining medical necessity. Medical decision making : an international journal of the Society for Medical Decision Making. May-Jun 2002;22(3):208-217. PMID 12058778 14. Beraldo FN, Veiga DF, Veiga-Filho J, et al. Sexual function and depression outcomes among breast hypertrophy patients undergoing reduction mammaplasty: a randomized controlled trial. Annals of plastic surgery. Dec 19 2014. PMID 25536204 15. Thibaudeau S, Sinno H, Williams B. The effects of breast reduction on successful breastfeeding: a systematic review. Journal of plastic, reconstructive & aesthetic surgery : JPRAS. Oct 2010;63(10):1688-1693. PMID 19692299 16. Chen CL, Shore AD, Johns R, et al. The impact of obesity on breast surgery complications. Plastic and reconstructive surgery. Nov 2011;128(5):395e-402e. PMID 21666541 17. Shermak MA, Chang D, Buretta K, et al. Increasing age impairs outcomes in breast reduction surgery. Plastic and reconstructive surgery. Dec 2011;128(6):1182-1187. PMID 22094737 18. Nelson JA, Fischer JP, Chung CU, et al. Obesity and early complications following reduction mammaplasty: An analysis of 4545 patients from the 2005-2011 NSQIP datasets. J Plast Surg Hand Surg. Oct 2014;48(5):334-339. PMID 24506446 19. Gust MJ, Smetona JT, Persing JS, et al. The impact of body mass index on reduction mammaplasty: a multicenter analysis of 2492 patients. Aesthetic surgery journal / the American Society for Aesthetic Plastic surgery. Nov 1 2013;33(8):1140-1147. PMID 24214951 20. American Society of Plastic Surgeons. Reduction Mammaplasty: ASPS Recommended Insurance Coverage Criteria for Third-Party Payers. 2011; http://www.plasticsurgery.org/Documents/medical-professionals/healthpolicy/insurance/Reduction_Mammaplasty_Coverage_Criteria.pdf 21. American Society of Plastic Surgeons. Evidence-based Clinical Practice Guideline: Reduction Mammaplasty. 2011; http://www.plasticsurgery.org/Documents/medical-professionals/healthpolicy/evidencepractice/Reduction_Mammaplasty_Evidence_Based_Guideline%20%282%29%282%29.pdf 22. Kalliainen LK. ASPS Clinical Practice Guideline Summary on Reduction Mammaplasty. Plastic and reconstructive surgery. Oct 2012;130(4):785-789. PMID 23018692s Billing Coding/Physician Documentation Information 19318 Reduction mammoplasty ICD-10 Codes Hypertrophy of breast Non-pressure chronic ulcer of skin of other sites limited to breakdown of skin M25.511- Pain in shoulder; code range M25.519 M54.89Dorsalgia; code range M54.9 N62 L98.491 Additional Policy Key Words Reduction mammoplasty Breast reduction Policy Implementation/Update Information 7/1/05 New policy added to the Surgery section. 7/1/06 No policy statement changes 10/1/06 Policy statement revised to clarify which criteria are required for determining medical necessity. Removed “impaired function or movement” from the list of criteria. Minimum amount of grams changed from 600 grams total to 500 grams per breast. Added the Schnur Sliding Scale to the list of criteria. 7/1/07 No policy statement changes. 7/1/08 No policy statement changes. 7/1/09 No policy statement changes. 7/1/10 No policy statement changes. 7/1/11 No policy statement changes. Body Surface Area calculator corrected. 7/1/12 No policy statement changes. 7/1/13 No policy statement changes. 7/1/14 No policy statement changes. 7/1/15 No policy statement changes 7/1/16 No policy statement changes. State and Federal mandates and health plan contract language, including specific provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The medical policies contained herein are for informational purposes. The medical policies do not constitute medical advice or medical care. Treating health care providers are independent contractors and are neither employees nor agents Blue KC and are solely responsible for diagnosis, treatment and medical advice. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, photocopying, or otherwise, without permission from Blue KC.
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